Magic Glass Evaluation in People With Stroke

Not Applicable

• Conditions: Stroke

• Registration Number: NCT04307108
• Lead Sponsor: University of Ulster

Brief Summary

Background: Virtual Reality (VR) technology may help to provide a way for stroke survivors to exercise in their own time at home, with remote clinical support. Before we introduce this technology we need to test that it will work alongside current health services for stroke survivors. Aims: To find out if using the MAGIC-GLASS solution alongside current healthcare care is usable and acceptable to stroke survivors and helps to increase rehabilitation time. Design: Measures before and after stroke survivors use the MAGIC-GLASS solution.

Setting: Stroke survivors will use the MAGIC-GLASS solution in their own home. Population: adults (≥18 years) who have had a stroke at least two weeks before they enter into the study.

Interventions: Our VR technology is called MAGIC-GLASS, and in order to use the solution the user puts on a headset which is connected to a computer. They can then see a VR environment in which they will be able to see virtual hands that respond to the movements of their own hands. It will also be possible to see a mirror image of their hands moving. The system will record how much they use the system and improvement in their movement. Regular contact will be made with a clinician who will be able to use the system to see (from their clinic) how the stroke survivor is doing and talk to them. Outcomes: We want to find out how the stroke survivors' movement changes over time and what they think of using the system. We will also ask clinical staff what they thought of using the system as part of healthcare provision to stroke survivors. Finally we want to find out how much it will cost to use the system.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-11
• Study First Submitted: 2020-02-17
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13
• Primary Completion: 2020-03-30
• Study Completion: 2020-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Any time point post stroke
• Medically stable (and without uncontrolled seizures or vertigo)
• No or mild cognitive deficit: can follow two step commands
• No significant visual or spatial neglect (Can turn head towards an image when asked to do so and keep attention). People with hemianopia or other visual deficits can be included dependent on clinical opinion
• Normal or normal corrected vision
• Be able to get in and out from a seat with assistance; can be used in a wheelchair as long as arms can rest on table
• Have a carer to assist putting on the headset
• Be willing to give consent
• For those not using mirror therapy, can move impaired arm without significant pain

Exclusion Criteria

• • People with a moderate to severe cognitive impairment (MoCA<20).

  • Those with a visual impairment who are unable to see a clear image with the headset.
  • Patients with severe neuropsychological deficits such as severe neglect or apraxia as indicated by their clinical team.
  • Patients who are medically unwell e.g. with history of solid organ or bone marrow transplantation, active malignancy within 24 months prior to screening or metastatic cancer, life expectancy less than 6 months, Congestive heart failure in New York Heart Association (NYHA) Functional Classification IV (severe) stage.
  • Those with complete dependency in Activities of Daily Living, any medical or other reason (e.g. known or suspected inability of the participant to comply with the protocol procedure) that investigator opinion that the participant is unsuitable for the study.
  • Patients unwilling to provide consent and those who cannot be followed-up at any time point will be excluded from the study.
  • Epilepsy, seizures and history of vertigo (possible exclusion determined by clinician).
  • Those with upper limb sensory disturbance who are unwilling to keep their nails short for the duration of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
the acceptability of the intervention	through study completion, an average of 6 months	Combination of interviews with users, carer questionnaire, focus groups with clinicians will be used to assess acceptability by analysing qualitatively
the usability of the intervention;	through study completion, an average of 6 months	Combination of interviews with users, carer questionnaire, focus groups with clinicians will be used to assess usability using qualitative analysis
the usability of the intervention	through study completion, an average of 6 months	System usability score questionnaire
the process requirements for the new care pathway;	through study completion, an average of 6 months	Combination of interviews with users, carer questionnaire, focus groups with clinicians and will be analysed qualitatively
the resource requirements for the new care pathway;	through study completion, an average of 6 months	Combination of interviews with users, carer questionnaire, focus groups with clinician and will be analysed qualitatively
the intensity in Rehabilitation Therapy	Change from baseline to end of intervention (6 months)	measured in clinical dashboard
the duration in Rehabilitation Therapy	Change from baseline to end of intervention (6 months)	measured in clinical dashboard

Secondary Outcome Measures

Name	Time	Method
physical activity as measured by range of motion	Change from baseline to end of intervention (6 months)	measured by sensors inbuilt in the computer system
potential cost effectiveness of the solution	Change from baseline to end of intervention (6 months)	health care resource questionnaire
Functional independence in the activities of daily living with respect to the modified Rankin Scale	Change from baseline to end of intervention (6 months)
cognitive function	Change from baseline to end of intervention (6 months)	Montreal Cognitive Assessment
Stroke specific quality of life	Change from baseline to end of intervention (6 months)	Stroke specific quality of life questionnaire
Functional independence in the activities of daily living with respect to the Barthel Index	Change from baseline to end of intervention (6 months)

Trial Locations

Locations (3)

Western Health and Social Care Trust; 🇬🇧 Derry, United Kingdom

Southern Health and Social Care Trust; 🇬🇧 Lurgan, United Kingdom

Neuro-rehabilitation Department of the University Hospital of Ancona.; 🇮🇹 Ancona, Italy